Pharmacovigilance Without Borders

Day 1: 9.00 a.m. – 5.00 p.m.

Day 2: 9.00 a.m. – 5.00 p.m.

Breaks will be arranged flexibly.

 

Content of the Course

Pharmacovigilance is increasingly shaped by international collaborations.
This course focuses primarily on two regions, each complex in its own right
and encompassing numerous countries and thus legal systems: Europe and
the GCC (Gulf Cooperation Council). The course addresses the regulatory
frameworks as foundations. Furthermore, it focuses on operational
challenges. It takes into account that companies — i.e. the MAHs —must
leverage regional synergies while simultaneously encountering countryspecific
details. Our seminar leaders, drawing on their diverse regional
projects and extensive experience, will explore how structures can be
developed and compliance ensured in these contexts.

The Regulatory Landscape: an Overview

• EU/UK/CH PV obligations for global safety oversight
• Overview of regional PV requirements:

– GCC (Gulf Cooperation Council) : UAE, Saudi Arabia, Qatar, Kuwait, Oman, Bahrain

– Levant: Jordan, Lebanon, and others

• Local QPPV/LSO (Local Safety Officer) requirements in Arab countries
• Requirements for reporting: domestic vs foreign cases
•  

Roles and Responsibilities Across the PV Network

• Global MAH responsibilities

– EU
– United Kingdom
– Switzerland

• Local MAH responsibilities: where are they applicable?
• Distributor responsibilities in Non-MAH markets
• Safety data flow: timelines, the format, and minimum data elements
• Escalation pathways for serious and critical events

PV Agreements and Contract Governance

• Required components of PVA

– Safety data exchange
– Timelines for key elements (ICSRs, complaints, recalls, signals)
– Local regulatory reporting obligations
– Inspections and audits
– Training requirements

• Managing multiple distributors in different Arab jurisdictions
• Change control and version management
• Oversight by the global MAH

Safety Data Collection and Global Database Management

• What is expected from distributors?

– AE/SAE collection processes
– Documentation standards
– Handling of literature cases

• Transfer of data to the global safety database
• Duplicate detection and case reconciliation
• Data privacy considerations

– The EU’s GDPR
– Relevant local laws and legal frameworks

Local Reporting Requirements in Arab Countries

• Case reporting

– Serious or non-serious
– Local vs foreign reporting

• Device vigilance (if applicable)
• Periodic reporting (PSUR, PBRER, RMP updates)
• Product quality complaints and defect reporting
• Variability across agencies (SFDA, MOHAP, DHA, DoH, JFDA, etc.)

Local Aspects in Saudi-Arabia: PV Compliance and Inspection Readiness

• PV: local requirements
• Relevant authorities in Saudi-Arabia
• Inspection readiness and preparation
• Experiences so far

Prof Saleh Bawazir, Professor of Clinical Pharmacy, CEO, Bawazir Pharma
Consult Center, Consultant GCC Regulatory Affairs, Saudi-Arabia

Inspection and Audit Readiness
Common inspection triggers

– EU/UK/Swiss
– Arab countries: the US FDA

Distributor expectations during inspections
MAH oversight responsibilities
Document management: SOPs, training, logs, case files
Mock inspection preparation
Inspection communication strategies

Signal Management and Risk Minimization

• Distributor responsibilities in signal detection support
• Local intelligence and pharmacovigilance insights
• Implementation of local risk minimization measures
• Communication to HCPs: safety alerts, DHPCs, recalls

Product Complaints, Recalls and Quality Defect Handling

• PV–Quality–Regulatory interface
• Complaint intake and triage
• Linking complaints to safety cases
• Local recall procedures (UAE, Saudi Arabia, Egypt, etc.)
• Joint responsibilities for FSCA/product withdrawal

Training and Competency Requirements

• Mandatory annual PV training for distributors: what is required?
• Documentation of competencies
• Training materials provided by MAH vs locally prepared and specific requirements

Governance Model and Performance Monitoring

• KPIs and metrics for distributors’ PV performance
• Case reporting timeliness
• Compliance tracking
• Periodic performance review